An interventional study of MY LIFE treatment and Care as Usual in Behavior Problem, sponsored by Amsterdam UMC, location VUmc. Status unknown at 1 site in Netherlands. Open to participants aged 14 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-17.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
Objective This study examines the effects of the MY LIFE treatment, a group intervention aiming to increase hope, self-worth and social support seeking in adolescents with behavioral problems in mental health care.
Method This study is a group randomized controlled trial to determine whether MY LIFE is effective, by comparing care as usual with care as usual plus the MY LIFE treatment. Groups of adolescents (N= 50 per arm, Age= 14-20) with behavioral problems will be randomly assigned to either the care as usual condition or the care as usual plus the MY LIFE treatment condition. The second part of the study is focused on the subjective evaluation of the intervention by the adolescents, using qualitative research methods.
Results Primary outcomes of the RCT are hope, self-worth, and seeking social support. As secondary outcomes emotional and behavioral symptoms are assessed. The second part of the study analyses the subjective evaluation of the MY LIFE treatment.
Treating adolescents with behavioral problems without motivation for change in youth mental healthcare is a challenge, and group interventions targeting these adolescents show low effectiveness. This seems even more pronounced in girls. Most interventions focus on behavioral change and include parental involvement. The MY LIFE treatment was designed to provide a treatment based on the needs of adolescents. A good working alliance is essential in treatment. For instance, the alliance between girls and staff in residential care, predicts treatment success, and a weak working alliance is associated with more behavioral problems. According to evaluations of successful treatments at our mental health department for complex behavioral problems, adolescents value the concepts of hope, self-worth and seeking support as well. Therefore, these concepts, as well as the working alliance, were key elements in the development of the MY LIFE treatment.
Hope This study uses Snyder's definition: "hope is a positive motivational state that is based on an interactively derived sense of successful (a) agency (goal-directed energy) and (b) pathways (planning to meet goals)" . The relevance of the concept of hope for adolescents with mental health problems has been widely studied. For instance, hope makes children resilient to adverse life events. The prevalence of adverse life events is high in children and adolescents with behavioral problems, which emphasizes the importance of addressing this concept in interventions for these adolescents.
Self-worth In this study self-worth is defined as a person's subjective evaluation of his or hers own worth. Low self-worth is related to aggression and antisocial behavior, and addressing this concept in the treatment of behavioral problems of adolescents may help to reduce aggressive and antisocial behavior.
Seeking support The definition of seeking support used here, is "having an active coping style when facing problems or stressful situations" . An active coping style leads to a greater well-being in adolescents. Therefore, teaching them an active coping style, such as seeking support, is important in an attempt to reduce behavioral problems and to foster well-being in adolescents witt behavioral problems. These findings suggest coping should be a target for intervention.
These three concepts are interrelated; active coping such as seeking support is related to more self-worth and vice versa: better social relationships lead to more self-worth. Furthermore, studies show that self- worth mediates the association of hope with life satisfaction.
Objectives and research questions
The study aims to examine the effectiveness of the MY LIFE treatment, answering the following questions:
Do adolescents with behavioral problems (age 14-20) have more hope, a higher level of self-worth and seek more support after receiving MY LIFE, in comparison to pre-treatment?
Secondary, this study focuses on the question:
Method Trial management The trial is funded by KFZ-J (Kwaliteit Forensische Zorg Jeugd) and led by a team of researchers and clinicians from the AmsterdamUMC and Levvel (youth mental health care).
Study design The study is a group randomized controlled trial, comparing Care As Usual (CAU) plus the MY LIFE treatment with a waitinglist control group receiving only CAU. The study procedure is depicted in figure 1. All adolescents and a chosen caretaker (CC) by the adolescent, will fill in questionnaires during a baseline assessment (T0). Six weeks later all adolescents and the CC will again fill in questionnaires during a post-measurement (T1). The waitinglist control group will receive the MY LIFE treatment after T1 and an additional post-measurement will be done after they have received the treatment (T2). All adolescents will be asked to fill in the questionnaires again 1 year after T0 (T3).
The Medical Ethics Review Committee of VU University Medical Center (METC) has reviewed the study protocol and concluded that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study. The Medical Ethics Review Committee of VU University Medical Center is registered with the US Office for Human Research Protections (OHRP) as IRB00002991. The FWA number assigned to VU University Medical Center is FWA00017598.
Data management Since this is the first study on the MY LIFE treatment, and this treatment is different than interventions used in this population, it is difficult to estimate the expected effect and also the required sample size. Furthermore, previous studies in similar populations have demonstrated a large variety in effectsized of CBT-based interventions, ranging from small (d=0.33) to large (d=0.98) effects. To calculate the sample size for this study we used G* Power, with an estimation effect of (d=0.5), a power of β=0.8 and an ICC=0.6 to correct for dependency between the repeated measures. This resulted in an N of 50 adolescents per arm (in total N= 100) for this RCT.
A group randomized controlled trial will be performed to evaluate the effect of the intervention. All groups will receive care as usual within their youth care facility. The treatment group will also receive the MY LIFE treatment. Castor, a data management software program, will be used to store the data. To analyse the data a multilevel model with a three level structure (repeated measures are clustered within participants, and participants are clustered within groups) will be used via SPSS (Statistical Package for the Social Sciences). Analyses will be performed twice: once based on intention-to-treat (we consider this our primary analysis), and once including only those adolescents who completed the intervention. Missing data is taken into account by the multilevel analyses. Outliers deviating 3SD from the mean will be excluded.
The qualitative data will be analysed using ATLAS.ti.
517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 391 interventional studies indexed under Problem Behavior.
Browse Problem Behavior studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adolescent is referred for behavioral problems
Exclusion Criteria:
School level is below BL (a school level in the Dutch school system)
Care as Usual and the MY LIFE treatment
Other: MY LIFE treatment
Care as Usual
Other: Care as Usual
The MY LIFE is a group treatment consisting of 5 workshops, for adolescents with a low motivation for mental health treatment. It aims to increase self- worth, hope for the future and seeking social support through exercises by using music and lyrics and other creative exercises to engage adolescents. The MY LIFE treatment also uses methods that stem from psychodynamic, cognitive behavioral, and solution focused theories. The therapeutic attitude is based on client-centered therapy of Rogers, which includes a genuine, positive regard and empathic understanding, focusing on the inner strength and growth potential of a person. Adolescents are never forced to participate during the workshops, merely encouraged. The core of the treatment is: the adolescent decides
The care as usual the adolescents receives
JIJ questionnaire
Hope/ Self-worth/ Seeking support Self report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
CHS (Children Hope Scale)
Hope Self report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
BSCI-Y (Beck Self- Concept Inventory for Youth)
Self-worth Self report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
UCL (S) Utrechtse Coping List Social support
Seeking support Self Report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
JIJ questionnaire BA
Hope/ Self -worth/ Seeking support. Form is filled in by a caregiver chosen by the adolescent.
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale self-worth
Self- Worth Form is filled in by caregiver chosen by the adolescent.
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale social support
Seeking support Form is filled in by caregiver chosen by the adolescent
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
SDQ (Strengths and Difficulties Questionnaire)
Emotional symptoms Conduct problems Hyperactivity/inattention Peer relationship problems Prosocial behavior Self report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
BDBI-Y (Beck Disruptive Behavior Inventory for Youth)
Disruptive behavior self report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
BANI-Y (Beck Anger Inventory for Youth)
Anger self report
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Workshop evaluation designed for the purpose of this study
Client satisfaction regarding workshop with three smilies. Self report
Time frame: per workshop so every week during the treatment, 5 times
Strengths and Difficulties Questionnaire (SDQ) for parents or teachers
Emotional symptoms, Conduct problems, Hyperactivity/Inattention, Peer relationship problems, Prosocial behavior
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale emotional difficulties
Emotional difficulties. Form is filled in by a caregiver chosen by the adolescent
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Evaluation of the MY LIFE treatment
evaluation by the adolescents of the MY LIFE treatment
Time frame: 6 weeks after start treatment
Plan to share: No — No sharing of data after the study. Merely for use in this particular study.
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Amsterdam UMC, location VUmc